Opinion
EDITORIAL
Changing the Narrative for Early Childhood Investment Jack P. Shonkoff, MD
Advances in the biological and social sciences tell us that the period from conception to school entry is a time of both significant opportunity and considerable risk. Multiple interventions during these early years have been designed to adAuthor Audio Interview at dress the roots of lifelong disjamapediatrics.com parities in learning, behavior, and health, and half a Related article page 114 century of program evaluation has documented positive impacts on a variety of outcomes. That said, the quality of program implementation has been highly variable and the magnitude of the impacts has remained fairly stable during the past several decades, consistently falling within the small to moderate effect-size range. The time has now come for a different approach to early childhood investment that catalyzes innovation, seeks far greater impacts, and views best practices as a baseline, not a solution.1,2 The cumulative knowledge base constructed by the architects of the Nurse-Family Partnership (NFP) during 3 decades has clearly earned high ranking on the list of best practices. This highly disciplined group of investigators has designed, refined, and scaled the most extensively studied intervention model in the prenatal and early childhood arena—and demonstrated a range of impacts on perinatal health, child wellbeing, and maternal life-course outcomes.3 The most recent NFP report adds new data on postintervention measures of child development at ages 6 and 9 years.4 Nurse-delivered services produced a mixed picture of behavioral benefits (in contrast to negligible effects from paraprofessionals), but no significant impacts on school achievement were found at either age. These data underscore the need for a deeper understanding of the adult capabilities that are strengthened by the NFP, the causal mechanisms that explain program effects on children, and the reasons why trained nurses achieve greater impacts than paraprofessionals. These findings also present a sober picture for decision makers seeking more effective strategies to strengthen the foundations of school success at a time when gaps in educational attainment associated with race have narrowed but disparities linked to family income have been growing and social mobility diminishing. 5 Moreover, while advances in biomedical research have produced dramatic progress in the treatment of children with cancer, cystic fibrosis, and human immunodeficiency virus/AIDS, persistent racial/ethnic and income disparities in key health indices have eluded solution. In this context, the limited extent to which new discoveries in neuroscience, molecular biology, and epigenetics have catalyzed more effective strategies to reduce the biological emjamapediatrics.com
bedding of early adversity presents an indefensible contrast.6 Growing evidence of the extent to which toxic stress can disrupt developing brain circuits, other maturing organs, and metabolic regulatory systems underscores the need for new interventions focused on reducing or mitigating the consequences of significant adversity.7,8 Three iconic intervention models that have been evaluated through randomized trials—the Perry Preschool Project, the Abecedarian Project, and the NFP—dominate the debate on early childhood investment. The 1960s Perry Preschool Project randomized trial (n = 123) studied 1 to 2 years of centerbased preschool for 3- to 4-year-olds, linked to weekly home visiting that included parent coaching by a highly trained teacher.9 The 1970s Abecedarian Project randomized trial (n = 111) studied 5 years of center-based child care beginning in early infancy and delivered by highly skilled staff, without an obligatory parent component.10 The NFP, which has been studied in thousands of families in multiple sites, provides structured home visiting by trained nurses from the prenatal period to age 2 years. All 3 studies demonstrate that programs staffed by well-trained professionals can produce multiple child and parent impacts but their service models are not comparable, their target populations differ, and their measured outcomes vary. The Perry Preschool Project and the Abecedarian Project produced short-term effects on cognitive measures and long-term impacts on high school graduation, economic selfsufficiency, and (for the Perry Preschool Project only) reduced incarceration. Public discourse on the economic benefits of early childhood intervention is based almost entirely on the Perry Preschool Project data, but few of the thousands of programs provided in the United States today are replications of that model. Likewise, advocacy for home visiting services typically cites the impacts of the NFP, but most programs do not meet its rigorous standards. The time is long overdue for the scientific community to clarify the evidence base for early childhood investment. Generic statements about program impacts that do not link specific interventions to specific outcomes have limited meaning. Effects on parent behavior are not the same as impacts on children, and changes in child behavior are not proxies for academic achievement. Significant progress will require the disciplined development of enhanced theories of change that are grounded in science and drive the design of explicit strategies focused on specific causal mechanisms to produce breakthrough gains on important outcomes. The fundamental challenge is not just the inability to produce larger impacts but also the absence of a research and development enterprise to encourage the development and testing of innovative strategies. Funding that is restricted solely JAMA Pediatrics February 2014 Volume 168, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archpedi.jamanetwork.com/ by a Grand Valley State University User on 06/09/2015
105
Opinion Editorial
to services with previously documented effectiveness eliminates the opportunity to try new things. Advancing the leading edge of innovation in research, policy, and practice across sectors will require community-based settings that provide the kind of environment in which creativity flourishes. This demands a flexible approach to planning and funding that encourages risk taking, promotes learning from failure, and supports continuous adaptation before an intervention is ready for a randomized trial. Its successful applic ation presents a dramatic contrast to conventional research, which requires strict adherence to a predetermined protocol and fixed period of data collection. The short-cycle nature of the innovation process feeds on continuous sharing of preliminary findings. The academic approach delays dissemination until the publication of peerARTICLE INFORMATION Author Affiliation: Center on the Developing Child, Harvard University, Cambridge, Massachusetts. Corresponding Author: Jack P. Shonkoff, MD, Center on the Developing Child, Harvard University, 50 Church St, Cambridge, MA 02138 ([email protected]). Published Online: December 2, 2013. doi:10.1001/jamapediatrics.2013.4212. Conflict of Interest Disclosures: None reported. REFERENCES 1. Shonkoff JP. Leveraging the biology of adversity to address the roots of disparities in health and development. Proc Natl Acad Sci U S A. 2012;109(2)(suppl 2):17302-17307. 2. Shonkoff JP, Levitt P. Neuroscience and the future of early childhood policy: moving from why to what and how. Neuron. 2010;67(5): 689-691.
reviewed results. The magnitude of this required cultural shift should not be underestimated, but the potential gains are huge and the status quo is untenable. A brighter future for children whose life prospects are threatened by adversity requires that we build on the seminal contributions of programs like the NFP and leverage advances in 21st-century science to catalyze fresh thinking that changes the narrative for early childhood investment. Improving program quality, enhancing service coordination, and scaling effective interventions are necessary but not sufficient. The marching orders are clear—we must embrace a spirit of constructive dissatisfaction with best practices, continually design and test new ideas, learn from things that do not work, and settle for nothing less than breakthrough impacts on important outcomes.
3. Olds DL. Prenatal and infancy home visiting by nurses: from randomized trials to community replication. Prev Sci. 2002;3(3):153-172. 4. Olds DL, Holmberg JR, Donelan-McCall N, Luckey DW, Knudtson MD, Robinson J. Effects of home visits by paraprofessionals and by nurses on children: follow-up of a randomized trial at ages 6 and 9 years [published online December 2, 2013]. JAMA Pediatr. doi:10.1001/jamapediatrics.2013.3817. 5. Reardon S. The widening academic achievement gap between the rich and poor: new evidence and possible explanations. In: Duncan G, Murnane R, eds. Whither Opportunity? Rising Inequality, Schools, and Children’s Life Chances. New York, NY: Russell Sage Press; 2011:91-116. 6. Shonkoff JP. Protecting brains, not simply stimulating minds. Science. 2011;333(6045): 982-983.
framework for health promotion and disease prevention. JAMA. 2009;301(21):2252-2259. 8. Shonkoff JP, Garner AS; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012;129(1):e232-e246. 9. Schweinhart LJ. Lifetime Effects: The High/Scope Perry Preschool Study Through Age 40. Ypsilanti, MI: High/Scope Press; 2005. 10. Campbell FA, Ramey CT. Effects of early intervention on intellectual and academic achievement: a follow-up study of children from low-income families. Child Dev. 1994;65(2, spec No.):684-698.
7. Shonkoff JP, Boyce WT, McEwen BS. Neuroscience, molecular biology, and the childhood roots of health disparities: building a new
Newborns, One of the Last Therapeutic Orphans to Be Adopted Justin L. Stiers, MD; Robert M. Ward, MD
Years of limited study of drugs in pediatric patients after 1962 left 75% to 80% of approved drugs lacking adequate pediatric prescribing information according to Shirkey1 in 1968 and later Wilson2 in 1999. In November 1997, bipartisan congresRelated article page 130 sional legislation provided a novel solution to this problem. The Food and Drug Administration (FDA) Modernization Act of 19973 provided an incentive of a 6-month extension of existing market protection/exclusivity for all products containing the active ingredient being tested in return for successful completion of pediatric studies specified by the FDA in a Written Request. Studies could include both on-label and off-label indications. This reward, designated the carrot, was complemented the next year by the 1998 Pediatric Final Rule, a stick that required 106
study of new drugs in pediatric patients for the indication that was proposed for approval in adults. Although the 1998 regulation was later overturned by Judge Kennedy as an illegal expansion of FDA authority, almost all of its provisions were codified by Congress in 2003 as the Pediatric Research Equity Act.4 The study of drugs in pediatric patients increased along with new pediatric labeling, propelled by a stick (Pediatric Research Equity Act) and a carrot (the Best Pharmaceuticals for Children Act [BPCA]). These were renewed in 2007 and made permanent in 2012.5 The success of these legislative experiments to increase pediatric studies of medications has been demonstrated by approval of the 500th pediatric label change in 2013.6 Not all pediatric patients benefited from the success of these legislations to increase the study of drugs in the pediatric population. By November 2002, 5 years after passage of
JAMA Pediatrics February 2014 Volume 168, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archpedi.jamanetwork.com/ by a Grand Valley State University User on 06/09/2015
jamapediatrics.com
EDITORIAL
Changing the Narrative for Early Childhood Investment Jack P. Shonkoff, MD
Advances in the biological and social sciences tell us that the period from conception to school entry is a time of both significant opportunity and considerable risk. Multiple interventions during these early years have been designed to adAuthor Audio Interview at dress the roots of lifelong disjamapediatrics.com parities in learning, behavior, and health, and half a Related article page 114 century of program evaluation has documented positive impacts on a variety of outcomes. That said, the quality of program implementation has been highly variable and the magnitude of the impacts has remained fairly stable during the past several decades, consistently falling within the small to moderate effect-size range. The time has now come for a different approach to early childhood investment that catalyzes innovation, seeks far greater impacts, and views best practices as a baseline, not a solution.1,2 The cumulative knowledge base constructed by the architects of the Nurse-Family Partnership (NFP) during 3 decades has clearly earned high ranking on the list of best practices. This highly disciplined group of investigators has designed, refined, and scaled the most extensively studied intervention model in the prenatal and early childhood arena—and demonstrated a range of impacts on perinatal health, child wellbeing, and maternal life-course outcomes.3 The most recent NFP report adds new data on postintervention measures of child development at ages 6 and 9 years.4 Nurse-delivered services produced a mixed picture of behavioral benefits (in contrast to negligible effects from paraprofessionals), but no significant impacts on school achievement were found at either age. These data underscore the need for a deeper understanding of the adult capabilities that are strengthened by the NFP, the causal mechanisms that explain program effects on children, and the reasons why trained nurses achieve greater impacts than paraprofessionals. These findings also present a sober picture for decision makers seeking more effective strategies to strengthen the foundations of school success at a time when gaps in educational attainment associated with race have narrowed but disparities linked to family income have been growing and social mobility diminishing. 5 Moreover, while advances in biomedical research have produced dramatic progress in the treatment of children with cancer, cystic fibrosis, and human immunodeficiency virus/AIDS, persistent racial/ethnic and income disparities in key health indices have eluded solution. In this context, the limited extent to which new discoveries in neuroscience, molecular biology, and epigenetics have catalyzed more effective strategies to reduce the biological emjamapediatrics.com
bedding of early adversity presents an indefensible contrast.6 Growing evidence of the extent to which toxic stress can disrupt developing brain circuits, other maturing organs, and metabolic regulatory systems underscores the need for new interventions focused on reducing or mitigating the consequences of significant adversity.7,8 Three iconic intervention models that have been evaluated through randomized trials—the Perry Preschool Project, the Abecedarian Project, and the NFP—dominate the debate on early childhood investment. The 1960s Perry Preschool Project randomized trial (n = 123) studied 1 to 2 years of centerbased preschool for 3- to 4-year-olds, linked to weekly home visiting that included parent coaching by a highly trained teacher.9 The 1970s Abecedarian Project randomized trial (n = 111) studied 5 years of center-based child care beginning in early infancy and delivered by highly skilled staff, without an obligatory parent component.10 The NFP, which has been studied in thousands of families in multiple sites, provides structured home visiting by trained nurses from the prenatal period to age 2 years. All 3 studies demonstrate that programs staffed by well-trained professionals can produce multiple child and parent impacts but their service models are not comparable, their target populations differ, and their measured outcomes vary. The Perry Preschool Project and the Abecedarian Project produced short-term effects on cognitive measures and long-term impacts on high school graduation, economic selfsufficiency, and (for the Perry Preschool Project only) reduced incarceration. Public discourse on the economic benefits of early childhood intervention is based almost entirely on the Perry Preschool Project data, but few of the thousands of programs provided in the United States today are replications of that model. Likewise, advocacy for home visiting services typically cites the impacts of the NFP, but most programs do not meet its rigorous standards. The time is long overdue for the scientific community to clarify the evidence base for early childhood investment. Generic statements about program impacts that do not link specific interventions to specific outcomes have limited meaning. Effects on parent behavior are not the same as impacts on children, and changes in child behavior are not proxies for academic achievement. Significant progress will require the disciplined development of enhanced theories of change that are grounded in science and drive the design of explicit strategies focused on specific causal mechanisms to produce breakthrough gains on important outcomes. The fundamental challenge is not just the inability to produce larger impacts but also the absence of a research and development enterprise to encourage the development and testing of innovative strategies. Funding that is restricted solely JAMA Pediatrics February 2014 Volume 168, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archpedi.jamanetwork.com/ by a Grand Valley State University User on 06/09/2015
105
Opinion Editorial
to services with previously documented effectiveness eliminates the opportunity to try new things. Advancing the leading edge of innovation in research, policy, and practice across sectors will require community-based settings that provide the kind of environment in which creativity flourishes. This demands a flexible approach to planning and funding that encourages risk taking, promotes learning from failure, and supports continuous adaptation before an intervention is ready for a randomized trial. Its successful applic ation presents a dramatic contrast to conventional research, which requires strict adherence to a predetermined protocol and fixed period of data collection. The short-cycle nature of the innovation process feeds on continuous sharing of preliminary findings. The academic approach delays dissemination until the publication of peerARTICLE INFORMATION Author Affiliation: Center on the Developing Child, Harvard University, Cambridge, Massachusetts. Corresponding Author: Jack P. Shonkoff, MD, Center on the Developing Child, Harvard University, 50 Church St, Cambridge, MA 02138 ([email protected]). Published Online: December 2, 2013. doi:10.1001/jamapediatrics.2013.4212. Conflict of Interest Disclosures: None reported. REFERENCES 1. Shonkoff JP. Leveraging the biology of adversity to address the roots of disparities in health and development. Proc Natl Acad Sci U S A. 2012;109(2)(suppl 2):17302-17307. 2. Shonkoff JP, Levitt P. Neuroscience and the future of early childhood policy: moving from why to what and how. Neuron. 2010;67(5): 689-691.
reviewed results. The magnitude of this required cultural shift should not be underestimated, but the potential gains are huge and the status quo is untenable. A brighter future for children whose life prospects are threatened by adversity requires that we build on the seminal contributions of programs like the NFP and leverage advances in 21st-century science to catalyze fresh thinking that changes the narrative for early childhood investment. Improving program quality, enhancing service coordination, and scaling effective interventions are necessary but not sufficient. The marching orders are clear—we must embrace a spirit of constructive dissatisfaction with best practices, continually design and test new ideas, learn from things that do not work, and settle for nothing less than breakthrough impacts on important outcomes.
3. Olds DL. Prenatal and infancy home visiting by nurses: from randomized trials to community replication. Prev Sci. 2002;3(3):153-172. 4. Olds DL, Holmberg JR, Donelan-McCall N, Luckey DW, Knudtson MD, Robinson J. Effects of home visits by paraprofessionals and by nurses on children: follow-up of a randomized trial at ages 6 and 9 years [published online December 2, 2013]. JAMA Pediatr. doi:10.1001/jamapediatrics.2013.3817. 5. Reardon S. The widening academic achievement gap between the rich and poor: new evidence and possible explanations. In: Duncan G, Murnane R, eds. Whither Opportunity? Rising Inequality, Schools, and Children’s Life Chances. New York, NY: Russell Sage Press; 2011:91-116. 6. Shonkoff JP. Protecting brains, not simply stimulating minds. Science. 2011;333(6045): 982-983.
framework for health promotion and disease prevention. JAMA. 2009;301(21):2252-2259. 8. Shonkoff JP, Garner AS; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012;129(1):e232-e246. 9. Schweinhart LJ. Lifetime Effects: The High/Scope Perry Preschool Study Through Age 40. Ypsilanti, MI: High/Scope Press; 2005. 10. Campbell FA, Ramey CT. Effects of early intervention on intellectual and academic achievement: a follow-up study of children from low-income families. Child Dev. 1994;65(2, spec No.):684-698.
7. Shonkoff JP, Boyce WT, McEwen BS. Neuroscience, molecular biology, and the childhood roots of health disparities: building a new
Newborns, One of the Last Therapeutic Orphans to Be Adopted Justin L. Stiers, MD; Robert M. Ward, MD
Years of limited study of drugs in pediatric patients after 1962 left 75% to 80% of approved drugs lacking adequate pediatric prescribing information according to Shirkey1 in 1968 and later Wilson2 in 1999. In November 1997, bipartisan congresRelated article page 130 sional legislation provided a novel solution to this problem. The Food and Drug Administration (FDA) Modernization Act of 19973 provided an incentive of a 6-month extension of existing market protection/exclusivity for all products containing the active ingredient being tested in return for successful completion of pediatric studies specified by the FDA in a Written Request. Studies could include both on-label and off-label indications. This reward, designated the carrot, was complemented the next year by the 1998 Pediatric Final Rule, a stick that required 106
study of new drugs in pediatric patients for the indication that was proposed for approval in adults. Although the 1998 regulation was later overturned by Judge Kennedy as an illegal expansion of FDA authority, almost all of its provisions were codified by Congress in 2003 as the Pediatric Research Equity Act.4 The study of drugs in pediatric patients increased along with new pediatric labeling, propelled by a stick (Pediatric Research Equity Act) and a carrot (the Best Pharmaceuticals for Children Act [BPCA]). These were renewed in 2007 and made permanent in 2012.5 The success of these legislative experiments to increase pediatric studies of medications has been demonstrated by approval of the 500th pediatric label change in 2013.6 Not all pediatric patients benefited from the success of these legislations to increase the study of drugs in the pediatric population. By November 2002, 5 years after passage of
JAMA Pediatrics February 2014 Volume 168, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archpedi.jamanetwork.com/ by a Grand Valley State University User on 06/09/2015
jamapediatrics.com
